Expanding Protection Against a Common Yet Serious Respiratory Virus
On October 23, 2023, the U.S. Food and Drug Administration (FDA) approved a new respiratory syncytial virus (RSV) vaccine for adults aged 60 and older, adding another tool to the growing arsenal of preventive options for older populations vulnerable to respiratory illness. This vaccine joins a small but expanding list of FDA-authorized RSV immunizations and is expected to significantly reduce the incidence of severe disease, hospitalization, and complications linked to RSV in aging adults.
The approval marks another important step in addressing seasonal RSV surges, which have increasingly strained the U.S. healthcare system in recent years. While often associated with infants, RSV is a major cause of respiratory infections among older adults, particularly those with underlying chronic conditions such as asthma, chronic obstructive pulmonary disease (COPD), and heart disease.
RSV: A Serious Threat to Older Adults
RSV is a common respiratory virus that typically causes mild, cold-like symptoms. However, in older adults—especially those over 60—it can lead to pneumonia, bronchiolitis, and worsening of chronic illnesses, often requiring hospitalization.
According to the Centers for Disease Control and Prevention (CDC):
- RSV causes an estimated 60,000 to 160,000 hospitalizations among older adults in the U.S. each year.
- It contributes to 6,000 to 10,000 deaths annually in this population.
- Immunosenescence—the natural decline in immune function with age—makes seniors particularly susceptible to severe outcomes from RSV infection.
Given the increased viral activity in recent years and the overlapping respiratory virus season with COVID-19 and influenza, the approval of this vaccine comes at a critical time for public health.
About the Vaccine and Its Efficacy
The newly approved vaccine is designed specifically for individuals aged 60 and above and utilizes a protein-based platform to generate immunity against RSV subtypes A and B. It was tested in a large, randomized, placebo-controlled Phase 3 clinical trial that included more than 35,000 participants.
Key findings from the study showed:
- Approximately 83% efficacy in preventing lower respiratory tract disease caused by RSV.
- Around 94% efficacy in preventing severe disease.
- No major safety concerns were identified; the most common side effects included injection site pain, fatigue, and mild fever.
The vaccine is expected to be available ahead of the 2024 RSV season, with the Advisory Committee on Immunization Practices (ACIP) expected to issue guidance on its use, including possible coadministration with other adult vaccines like influenza and COVID-19 boosters.
Public Health Impact and Policy Considerations
With the approval of this new RSV vaccine, older adults now have expanded preventive options. The approval also complements earlier 2023 FDA authorizations of Abrysvo (Pfizer) and Arexvy (GSK)—both approved earlier this year for the same age group and for pregnant individuals to protect newborns.
Public health officials anticipate that increased uptake of RSV vaccines among seniors will:
- Help alleviate seasonal pressure on hospitals and emergency departments.
- Reduce complications and mortality in high-risk populations.
- Promote integrated adult immunization strategies that address RSV, flu, and COVID-19 together.
To maximize impact, experts emphasize the importance of clear public education, strong provider recommendations, and equitable access, particularly for underserved older adults and communities of color disproportionately affected by respiratory illnesses.
Looking Forward
The FDA’s continued focus on RSV prevention reflects growing recognition of the virus as a serious, yet historically under-addressed threat to adult health. As more data becomes available and additional RSV vaccines enter the market, experts hope to build broader adult immunization infrastructure and strengthen preparedness for future respiratory virus outbreaks.
Older adults and their caregivers are encouraged to speak with healthcare providers about RSV vaccination options and determine eligibility and timing ahead of the upcoming respiratory illness season.
Source:
U.S. Food and Drug Administration – FDA Approves RSV Vaccine for Adults 60+
